Flap Preconditioning by Intermittent Negative Pressure

Lappenpräkonditionierung Durch Intermittierende Negative Drucktherapie - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03900065

Enrollment

Registered

2019-04-02

Start date

2019-01-01

Completion date

2020-07-01

Last updated

2019-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Surgical Procedure, Flap Ischemia

Keywords

flap preconditioning

Brief summary

A randomized controlled trial to investigate the effect of negative pressure preconditioning of flaps on surgical outcome and microcirculation of the tissue.

Detailed description

Flap surgery relies on the perfusion of the transposed or transplanted tissue. Distal parts of flaps are at risk of ischemia leading to wound complications and reoperation. The potential benefit of a preconditioning protocol using foam mediated negative pressure on the flap before surgery is to be examined.

Interventions

PROCEDUREPreconditioning

Foam-mediated intermittent negative pressure will be applied to the skin of the planned flap for 5 days before surgery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomized control trial comparing no preconditioning to preconditioning.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* All patients receiving a free or pedicled musculocutaneous M. latissimus dorsi-flap with the time frame of 5 days preconditioning.

Exclusion criteria

* Infection of skin of planned flap.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of hypoperfused skin island	up to 7 days postoperatively	The percentage of hypoperfused skin island should be measured clinically after surgery
Skin oxygen saturation of distal flap	1 day postoperative	The skin oxygen saturation of distal flap is measured via laserdoppler

Secondary

Measure	Time frame	Description
Wound complications	up to 12 weeks postoperatively	wound complications including need of surgical reoperation are assessed
VEGF expression in skin and muscle of flap	once during surgery	Laboratory examination of tissue specimen obtained during surgery
Density of flap dermal vessels	once during surgery	Laboratory examination of tissue specimen obtained during surgery

Countries

Germany

Contacts

Primary ContactMehran Dadras, MD

mehran.dadras@bergmannsheil.de+492343023560

Backup ContactBjörn Behr, MD

bjorn.behr@rub.de+492343023443

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026